christopher l. coffin (pro hac vice michael d. woerner ...corrected)_dkt116... · zoloft’s...

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Christopher L. Coffin (pro hac vice) [email protected] Nicholas R. Rockforte (pro hac pending) [email protected] David M. Hundley (pro hac pending) [email protected] Pendley, Baudin & Coffin, L.L.P. 1515 Poydras St., Suite 1400 New Orleans, LA 70112 Telephone: (504) 355-0086 Facsimile: (504) 523-0699 S. Samuel Griffin (pro hac vice) [email protected] LAW OFFICE OF S. SAMUEL GRIFFIN 1130 Piedmont Ave, N.E., # 908 Atlanta, GA 30309 Telephone: (404) 683-1915 Attorneys for Plaintiff and Putative Class

Michael D. Woerner (pro hac pending) [email protected] Gretchen Freeman Cappio (pro hac pending) [email protected] Benjamin Gould (SBN: 250630) [email protected] Alison Gaffney (pro hac pending) [email protected] Keller Rohrback L.L.P. 1201 Third Avenue, Suite 3200 Seattle, Washington 98101 Telephone: (206) 623-1900 Juli E. Farris (SBN: 141716) [email protected] Khesraw Karmand (SBN: 280272) [email protected] Keller Rohrback L.L.P. 1129 State Street, Suite 8 Santa Barbara, California 93101 Telephone: (805) 456-1496

UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF CALIFORNIA

SAN JOSE DIVISION

LAURA A. PLUMLEE, an individual, on behalf of herself and all other persons similarly situated, Plaintiff, vs. PFIZER, INC., a New York Corporation, Defendant.

Case No. 13-CV-0414-LHK FIRST AMENDED COMPLAINT CLASS ACTION DEMAND FOR JURY TRIAL

Case5:13-cv-00414-LHK Document116 Filed03/13/14 Page1 of 51

INTRODUCTION .................................................................................................................... 2

NATURE OF ACTION ............................................................................................................ 2

PARTIES .................................................................................................................................. 5

JURISDICTION AND VENUE ............................................................................................... 6

FACTUAL BACKGROUND ................................................................................................... 6I. THE PLACEBO EFFECT AND CLINICAL TRIALS ...................................................... 9II. ZOLOFT’S LACKLUSTER EFFICACY DATA ............................................................ 13III. THE FDA’S APPROVAL OF ZOLOFT .......................................................................... 16IV. PFIZER ENGAGED IN MISLEADING AND DECEPTIVE MARKETING OF

ZOLOFT ........................................................................................................................... 21A. The Drug Label ........................................................................................................... 21B. Selective Publication of Clinical Trial Data ............................................................... 24C. Pfizer’s Ghostwriting Program ................................................................................... 25D. Paid-For Opinions and Conflicts of Interest ............................................................... 27E. Zoloft’s Massive Efficacy Promotion Campaign ....................................................... 28

V. SPECIFIC OMISSIONS ................................................................................................... 31VI. PLAINTIFF-SPECIFIC ALLEGATIONS ....................................................................... 33

CONSUMER CLASS ALLEGATIONS ................................................................................ 36

COUNT I ................................................................................................................................ 39

COUNT II ............................................................................................................................... 41I. Unlawful Business Practices ............................................................................................. 42II. Fraudulent Business Practices ........................................................................................... 42III. Unfair Business Practices ................................................................................................. 43

COUNT III .............................................................................................................................. 43

EXEMPLARY DAMAGES ALLEGATIONS ....................................................................... 47

DEMAND FOR JURY TRIAL .............................................................................................. 48

PRAYER FOR RELIEF ......................................................................................................... 48


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INTRODUCTION

1. This matter arises from Defendant Pfizer, Inc.’s (“Pfizer”) deceptive and unlawful

marketing of the “blockbuster” antidepressant, Zoloft (generically known as sertraline). This

case is about a failure to inform—Pfizer deliberately withheld and actively concealed material

information about Zoloft’s inability to outperform placebo in treating depression. Specifically,

Pfizer concealed from consumers and prescribers that (1) the majority of clinical trials designed

to test Zoloft’s efficacy in treating depression indicated Zoloft was not superior to a placebo; (2)

that in the two clinical trials where Zoloft appeared to outperform placebo the difference was so

marginal it was clinically insignificant; and (3) that in the years following Zoloft’s approval by

the FDA, at least a dozen placebo-controlled clinical trials designed to measure Zoloft’s efficacy

in treating depression failed to show any statistical or clinical difference between Zoloft and

placebo. The injury caused by this conduct derives from the way consumers make decisions

about purchasing drugs. Each consumer has a right to know the risks and benefits of a drug

before they buy it. Consumers are entitled to weigh the risks and benefits of a drug to make a

decision as to whether the risks of the drug outweigh the likelihood of benefit. Here, Pfizer

concealed material information about the likelihood of benefit, i.e., information about Zoloft’s

inability to outperform placebo in a majority of the clinical trials designed to test Zoloft’s

efficacy in treating depression, and thereby robbed the Plaintiff and each consumer of their basic

right to make an informed decision about their mental healthcare. That violation is what gives

rise to this lawsuit.

NATURE OF ACTION

2. Although this lawsuit does not allege that Zoloft failed to treat every consumers’

depression, it does center on Pfizer’s suppression and concealment of Zoloft’s efficacy data—

data indicating that Zoloft could not meaningfully outperform placebo in treating depression in

the majority of its clinical trials.1 Indeed, the majority of placebo-controlled clinical trials 1 In determining whether a drug is effective, researchers are required to test a drug against a

placebo. Researchers must control for the placebo effect to ensure that any benefit observed in a patient taking an experimental drug is actually the result of the drug, and not the person’s desire to get better.


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designed to test Zoloft’s efficacy have shown that Zoloft cannot statistically outperform placebo,

and all of Zoloft’s placebo-controlled clinical trials have shown that Zoloft cannot clinically

outperform placebo.2

3. Long before Zoloft was put to market, Pfizer knew Zoloft had a problem

outperforming placebo. Early clinical trials indicated Zoloft lacked efficacy over placebo and,

under federal law, unless at least one clinical trial demonstrates a drug’s efficacy with some

supporting evidence, the Food and Drug Administration (“FDA”) cannot approve the drug. See

21 U.S.C. § 355(d). Knowing it only needed one positive trial with some supporting evidence,

Pfizer organized several efficacy trials that, based on previous trial results, were carefully

designed to suppress placebo response so that Zoloft would appear to be superior to placebo.

However, despite Pfizer’s best efforts, three of the five trials that were ultimately submitted to

the FDA showed that Zoloft was no more effective than placebo—meaning Zoloft could not

statistically outperform placebo. And, the two “positive” trials were also not particularly

supportive of efficacy. One of the “positive” trials showed an inverse dose response, meaning

patients taking higher doses of Zoloft responded worse than patients taking lower doses. In the

other “positive” trial, the difference between patients taking Zoloft and placebo, while

statistically significant, was clinically insignificant. Indeed, none of the placebo-controlled

clinical trials yielded a clinically significant result.

4. Pfizer submitted the two “positive” studies to the FDA, seeking approval for

Zoloft in the treatment of depression. The FDA, however, found it difficult to confirm Zoloft’s

efficacy in the face of so many clinical trials showing no efficacy. The FDA was also concerned

that any observed statistical benefit of Zoloft over placebo was clinically insignificant. After

wrestling with the issues, the FDA ultimately concluded that the two trials were sufficient to

meet the lax FDA efficacy requirements and, thus, the FDA was required under law to approve

2 Statistical significance refers to the ability of a drug to outperform placebo such that the

difference observed cannot only be attributed to chance or random probability. Clinical significance, which is a more meaningful metric, examines whether a drug outperforms placebo to such an extent that it would make a meaningful difference in the patient’s life or treatment. This distinction between statistical and clinical significance is explained in further detail below.


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the drug despite these concerns. Accordingly, Zoloft was approved for the treatment of

depression.

5. Under California law, as a pharmaceutical company with extensive knowledge of

its product, Pfizer is obligated to disclose all material information to consumers and prescribers

about its drugs, i.e., information that would likely affect the purchasing decisions of a reasonable

consumer. However, instead of complying with California law by making frank disclosures to

consumers and prescribers about the data supporting and undermining Zoloft’s likelihood of

efficacy in treating depression, Pfizer concocted a comprehensive and aggressive scheme to

mislead consumers and prescribing healthcare professionals. The scheme started with Zoloft’s

drug label,3 which was and continues to be directed at every consumer and prescribing healthcare

professional in the United States. Knowing that consumers and prescribing healthcare

professionals rely heavily on the risk and efficacy disclosures in the label, Pfizer artfully omitted

material information about Zoloft’s negative efficacy information to deliberately manipulate

consumer expectation. Zoloft’s drug label, as it existed in 1991 and until the present, does not

mention or discuss the numerous clinical trials (pre-approval and post-approval) in which Zoloft

could not outperform placebo in treating depression. Moreover, the label fails to disclose that in

the two clinical trials that supposedly demonstrate Zoloft’s efficacy, they only showed a

marginal or slight effect on treating depression. Instead, Pfizer concocted a description which,

through the artful omission of material facts, conveys the impression that Zoloft efficacy is

categorically superior to placebo in treating depression. In effect, Pfizer got a D minus to get

FDA approval, but promoted Zoloft as if it got an A. Because the drug label contains material

omissions of fact, Pfizer prevented consumers and prescribing healthcare professionals from

having enough information to make an informed decision about whether to purchase or prescribe

Zoloft.

6. Supplementing the misleading drug label, Pfizer also engaged in a larger scheme

to mislead consumers and prescribing healthcare professionals about Zoloft. Specifically, Pfizer:

3 Throughout this Complaint, the term “drug label” refers to the product insert and various

labels that are required by federal law to accompany a prescription medication.


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a. Selectively published clinical efficacy data and actively suppressed

negative data publication;

b. Paid well-respected medical professionals to put their names on articles

authored by Pfizer to tout specific efficacy messages, all while concealing

Pfizer’s involvement in the publication;

c. Paid key opinion leaders to tout Zoloft’s efficacy;

d. Spent hundreds of millions on direct-to-consumer advertising and

physician-targeted “training” and sale-aids, designed to convince

consumers and prescribing healthcare professionals that Zoloft was very

effective at treating depression.

7. Pfizer knew that disclosing Zoloft’s true efficacy data to consumers and

prescribing healthcare professionals would have drastically reduced revenue potential. So,

instead of being honest and straightforward with consumers and prescribing healthcare

professionals and allowing them to decide, for themselves, if Zoloft’s likelihood of benefit

outweighed its risks, Pfizer hid the efficacy data and mislead consumers and prescribing

healthcare professionals. The deception worked. Since 1991, Pfizer has sold over $30 billion in

Zoloft to consumers within the United States.

8. Plaintiff Laura A. Plumlee (“Plaintiff”), like many Zoloft consumers within the

State of California, purchased and ingested Zoloft to treat depression. She believed, relying on

Zoloft’s drug label and Pfizer’s extensive marketing and promotion, that Zoloft would help her

manage the symptoms related to depression. She, however, was never informed about Zoloft’s

negative efficacy information. Instead, Plaintiff, like many consumers within California, was

misled into purchasing an expensive and side-effect-ridden antidepressant without knowing the

full picture. She would never have purchased the drug if she had known the truth

9. Plaintiff brings this First Amended Complaint on behalf of herself and all

consumers within the State of California, seeking a refund of monies that were used to purchase

Zoloft for the treatment of depression.

PARTIES


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10. Plaintiff Laura A. Plumlee is, and was at all material times herein, a citizen,

resident, and domicile of the State of California, County of Santa Cruz.

11. Defendant Pfizer Inc. is a New York corporation with its headquarters in New

York, New York. Pfizer is, and was at all material times herein, a pharmaceutical company

involved in the research, development, testing, manufacture, production, distribution, marketing,

and sale of numerous pharmaceutical products, including Zoloft (generically known as

sertraline). Pfizer regularly conducts business, including the sale and marketing of Zoloft, within

the State of California.

JURISDICTION AND VENUE

12. This Court has subject-matter jurisdiction pursuant to 28 U.S.C. § 1332(d)(2).

Members of the proposed California Consumer Class are citizens of a different state than Pfizer.

Furthermore, the aggregate amount in controversy exceeds $5,000,000.

13. This Court has personal jurisdiction over Pfizer because Pfizer has purposefully

directed its marketing and sales of numerous pharmaceutical products to the State of California.

Pfizer has had substantial contacts with the State of California such that maintenance of the

action is consistent with traditional notions of fair play and substantial justice.

14. Venue is proper before this Court pursuant to 28 U.S.C. § 1391(b) and Local Civil

Rule 3-2(e). A substantial portion of the events giving rise to the claims alleged in this

Complaint took place within the Northern District for the District of California.

FACTUAL BACKGROUND

15. The market for antidepressants is large and competitive. Since the emergence of

“blockbuster” antidepressants in the 1980s, a multi-billion dollar industry has taken hold in the

United States and Europe. The antidepressant industry generates revenue in excess of $11

billion each year and the market continues to grow annually. There are dozens of brand name

and generic drugs approved by the Food and Drug Administration (“FDA”) for the treatment of

depression. Due to the availability of so many different antidepressants, prescribing physicians

and consumers typically “shop around” when trying to find the right drug. Thus, in order to

remain competitive in the antidepressant market, pharmaceutical companies spend hundreds of


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millions of dollars each year promoting directly to consumers and the medical community. The

number of drug commercials on television today speaks to the competitive nature of the industry.

16. Pfizer is one of the largest pharmaceutical companies in the world with annual

revenues exceeding $65 billion. Pfizer is a leader in the antidepressant industry and has enjoyed

considerable financial success from the manufacture and sale of Zoloft.

17. Zoloft (generically known as sertraline) is a selective serotonin reuptake inhibitor

(“SSRI”) in the same class of drugs as Prozac (generically known as fluoxetine) and Paxil

(generically known as paroxetine). It has been theorized that reduced levels of serotonin in the

brain are the primary physiological cause of depression and, through use of an SSRI such as

Zoloft, one could “balance the brain’s chemistry” and increase otherwise deficient serotonin

levels. Although scientists have never found evidence to prove the “balancing brain chemistry”

theory, Pfizer has successfully used the theory to promote the use of Zoloft.

18. The process of gaining FDA approval for a new drug involves several steps.

First, the company must conduct laboratory testing in animals to determine whether the drug will

be safe and, to some extent, effective. If animal testing indicates that the drug or compound is

relatively safe, the company then submits an investigational new drug (“IND”) application to the

FDA to gain approval to test the product with human subjects. These tests are called clinical

trials and are carried out sequentially in three phases—Phase I, II, and III studies. Each phase

increases the number of subjects and is designed to test for safety and efficacy of the drug for

specific indications and patient populations. After the clinical trials are completed, the company

then compiles the data and analysis in a new drug application (“NDA”). FDA reviews the NDA

with three major concerns: (1) safety and effectiveness in the drug’s proposed use; (2)

appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to assure

the drug’s strength, quality, and identity. Although the FDA evaluates the NDA to determine

whether the drug will be salable to the public, the company manufacturing the drug always bears

the responsibility of ensuring that the drug is manufactured, promoted, and labeled correctly.4

4 See Wyeth v. Levine, 555 U.S. 555, 570 (2009) (holding that, regardless of any FDA

approval, pharmaceutical manufactures bear sole responsibility for the sufficiency of a drug label).


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The United States Supreme Court and numerous other federal courts have held that the FDA’s

regulation and approval of drugs sets the floor, not the ceiling, of drug regulation.

19. When a drug is approved by the FDA, it means the drug manufacturer satisfied

the regulatory requirements set forth in the Food Drug and Cosmetic Act (“FDCA”). It does not

mean that the drug meets all state law requirements. In getting FDA approval, a drug

manufacturer submits a NDA which contains, among other things, “full reports of investigations

which have been made to show whether or not … such drug is effective in use” and “the labeling

proposed to be used for such drug[.]” 21 U.S.C. § 355 (b)(1)(A) and (b)(1)(F). Once the NDA is

complete, the FDA has six months to review the application. Id. at § 355(c)(1). The FDA must

either “[a]pprove the application” or “[g]ive the applicant notice of an opportunity for a hearing”

to determine “whether such application is approvable.” Id. at § 355(c)(1)(A)-(B). At the

hearing, the FDA can deny an application only if it makes one of seven enumerated findings. Id.

at § 355(d)(1)-(7). In the context of efficacy, since the FDA does not conduct its own clinical

trials, its role is circumscribed. The FDA can only deny an application if it finds the application

lacks “substantial evidence that the drug will have the effect it purports or is represented to

have[.]” Id. at § 355(d)(5). The FDCA mandates that the FDA approve an application unless it

finds the application lacks substantial evidence of efficacy. “Substantial evidence” is defined

under 21 U.S.C. § 355(d) as

[E]vidence consisting of adequate and well-controlled investigations … on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. If the Secretary determines, based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness, the Secretary may consider such data and evidence to constitute substantial evidence[.]

20. Similarly, the FDA does not draft the drug label. The drug manufacturer submits

proposed labeling and, unless the FDA finds, under FDCA standards, that the label is misleading,

it must approve it. 21 U.S.C. § 355(d). This does not mean the label meets disclosure

requirements created by state law. It merely means the FDA did not issue a finding that the label

is misleading under the FDCA. See, e.g., Schedin v. Ortho-McNeil-Janssen Pharm., Inc., 776 F.


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Supp. 2d 907, 915 (D. Minn. 2011) (FDA’s approval of a label “creates a floor below which no

label in the class can fall, but does not preclude a manufacturer from including more information

in its label.”).

21. The history of Zoloft dates back to the early 1970s. A scientist at Pfizer named

Reinhard Sarges discovered a new series of psychoactive compounds based on the structures of

thiothixene, neuroleptics and chlorprothixene. This eventually led him to the development of

tametraline, a weak dopamine reuptake inhibitor. The initial research into tametraline was halted

after scientists noticed unwanted stimulant effects in animals. However, in 1977, two other Pfizer

researchers, Kenneth Koe and Willard Welch, began working with some untested tametraline

compounds, which produced a serotonin reuptake inhibitor. After the new drug was tested on

animals, the chemical compound was named sertraline by Pfizer.

22. In the 1980s, sertraline underwent human clinical trials for the treatment of

depression, and in 1991 the FDA approved sertraline for the treatment of major depressive

disorder (“MDD”). It was released by Pfizer under the brand name Zoloft in 1991. In later

years, Zoloft gained approval for the treatment of other indications including obsessive-

compulsive disorder, panic disorder, post-traumatic stress disorder, premenstrual dysphoric

disorder, and social anxiety disorder.

23. Commercially, Zoloft has been an enormous success. It is estimated that, since

Zoloft’s launch in 1991, Zoloft sales have generated over $30 billion in revenue for Pfizer. Prior

to Zoloft’s patent expiration in 2007, which resulted in a proliferation of less expensive generic

versions of the drug, Zoloft’s annual sales were over $3 billion annually. Since 2007, however,

Zoloft has sold approximately $500 million each year. Currently, over 20 million prescriptions

of Zoloft and generic sertraline are filled annually.

I. THE PLACEBO EFFECT AND CLINICAL TRIALS

24. All drugs are subject to the placebo effect. The placebo effect is the perceived or

actual improvement in a medical condition that a patient receives from a medically ineffective

treatment that the patient believes to be effective. It has been demonstrated that the simple belief

that one is possibly experiencing medical treatment is, alone, sufficient to create significant


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improvement in a patient for many conditions. The exact cause of the placebo effect is a matter

of academic and scientific debate, but its effect on medical treatment is well documented.

25. Because of the placebo effect, before a drug is considered effective, it must

demonstrate that it is superior to placebo. Since all drugs contain side-effects, a physician must

be sure that the potential benefits of a drug outweigh its risks. If a drug is not able to outperform

placebo (a sugar pill without any relevant side effects) in any meaningful way, then the drug

should not be prescribed. Indeed, the central precept of medical ethics is that the physician

should primum non nocere (first, do no harm). This is why researchers must control for the

placebo effect when evaluating the efficacy of a drug. This is done using double-blind placebo-

controlled clinical trials.5 Trial participants are divided (unbeknownst to them) into a treatment

group, where the participants receive the drug, or a control group, where they receive a placebo.

Researchers then observe the results of the drug on the participants to see if the participants in

the treatment group respond to the medication better than those taking a placebo. If there is no

meaningful difference between the treatment and control group, then the drug is not considered

effective.

26. The placebo effect plays a significant role in the efficacy associated with

antidepressants. Unlike other ailments, where objective measurements are obtainable through

blood and tissue samples, there does not exist a physiological test for determining the extent of a

person’s depression. Rather, researchers must rely exclusively on the subjective articulations of

5 The history of placebo control groups in drug trials can be traced to a lie told by an Army

nurse during World War II. The nurse was assisting an anesthetist named Henry Beecher, who was tending to U.S. troops under heavy German bombardment. When the morphine supply ran low, the nurse assured a wounded soldier that he was getting a shot of potent painkiller, though her syringe contained only a saline solution. Amazingly, the injection relieved the soldier’s agony and prevented the onset of shock. Returning to his post at Harvard after the war, Dr. Beecher became one of the nation’s leading medical reformers. He launched a crusade to promote a method of testing new medicines to find out whether they were truly effective. Dr. Beecher proposed that if test subjects could be compared to a group that received a placebo, health officials would finally have an impartial way to determine whether a medicine was actually responsible for making a patient better. He published his findings in a 1955 paper titled, “The Powerful Placebo,” in The Journal of the American Medical Association, and described how the placebo effect had undermined the results of more than a dozen trials by causing improvement that was mistakenly attributed to the drugs being tested. By 1962, reeling from news of birth defects caused by thalidomide, Congress amended the Food, Drug, and Cosmetic Act (the Kefauver Harris Amendment, Pub. L. No. 87-781, 76 Stat. 780 (1962)) requiring trials to include placebo control groups.


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patients concerning their depression. This is done using questionnaires completed by patients or

their doctors designed to measure the severity of a patient’s depression. However, this subjective

measurement increases the potential for the placebo effect to drive the perceived efficacy of an

antidepressant in a clinical trial. Specifically, if a patient believes she is feeling better because

she is taking a drug that “cures” depression, unrelated to whether she is taking a particular

antidepressant or not, she will be more inclined to respond positively to questions about her

symptoms and appear better to the doctor observing the patient in a way that shows an

improvement. For example, an analysis of efficacy data submitted to the FDA between 1987 and

1999 for six of the most popular new generation antidepressants indicate that more than 80% of

the response to medication observed in clinical trials testing antidepressant efficacy was

duplicated by placebo. See Irving Kirsch et al., The Emperor’s New Drugs: An Analysis of

Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration, 5

Prevention & Treatment 23, 1-11 (2002), and Irving Kirsch et al., Initial severity and

antidepressant benefits: A meta-analysis of data submitted to the Food and Drug Administration,

5 PLOS MEDICINE 2, 0260-68 (2008); see Jay C. Fournier, et al., Antidepressant Drug Effect and

Depression Severity: A Patient-Level Meta-analysis, 303 J. AM. MED. ASSOC. 47-53, 47 (2010).

These studies do not provide any specific detail on Zoloft itself, but provide a general overview

of the efficacy issue for SSRIs.

27. Researchers use two metrics to determine whether the difference seen between a

treatment group and a control group in a placebo-controlled clinical trial is sufficient to consider

the drug “effective” for the purposes for which it was tested.

28. The first determinant is whether the difference seen between the treatment and

control group is statistically significant. Statistical significance means that the observed effect in

a population, here the difference between the treatment and control group, was not the result of

chance. It suggests, based on probability, that there is, on average, an actual difference between

the observed results.

29. The second determinant is whether the difference seen between the treatment and

control group was clinically significant, i.e. based on direct observation of the effect on a patient


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in a clinical setting. As the name suggests, clinical significance deals with whether the use of the

drug, based on how it outperforms placebo, is sufficient to make a meaningful difference in a

patient’s life. Estimates of clinical significance are needed to establish whether the observed

benefit of a drug in the treatment group over the control group is sufficient to outweigh the risks

associated with the drug, particularly when compared to alternative, less risky treatments. If a

drug is shown to be statistically superior to placebo, it may not be clinically significant because

the additional benefit may be so marginal that alternative treatments would be preferable. This is

particularly important when weighing the observed benefits against the known risks of treatment.

30. The use of placebo controlled clinical trials to ascertain a drug’s efficacy is the

generally accepted way to determine the efficacy of a drug. Indeed, one of the biggest reforms

of the FDCA came in 1962, when Congress amended the FDCA to require all new drugs to have

efficacy established by placebo-controlled trials. In the 1970s, several drug companies

(including Pfizer), see, e.g., Pfizer, Inc. v. Richardson, 434 F.2d 536, 540 (2d Cir. 1970), sought

to oppose this new requirement by arguing that testimonials, clinical impression, and practical

experience were sufficient to establish efficacy. See Pharm. Mfrs. Ass’n v. Richardson, 318 F.

Supp. 301, 309-10 (D. Del. 1970) (providing an in-depth account). Drug companies asserted that

subjective accounts by prescribers and patients were enough to show that a drug was effective

and suitable for sale. The courts, however, rejected this self-serving view:

In a great many instances during the past, drug companies have relied upon testimonials, clinical impressions, practical experience, and unsubstantiated subjective views of medical practitioners as evidence supporting their claims of efficacy for pre-1962 drugs. . . . such medical experience derived from random observations, isolated case reports and subjective impressions standing alone cannot [satisfy] the objective test of scientifically controlled investigations which Congress intended.

Id.

31. This view was further expressed by the United States Supreme Court, which

noted that the 1962 amendments and subsequent regulations “express well-established principles

of scientific investigation” and that “their strict and demanding standards, barring anecdotal

evidence indicating that doctors ‘believe’ in the efficacy of a drug, are amply justified by the

legislative history.” Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 619 (1973).


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The Court explained that “[t]he hearings underlying the 1962 Act show a marked concern that

impressions or beliefs of physicians, no matter how fervently held, are treacherous.” Id.

Whether a drug is effective is not a question of individual belief, but of well-controlled

observation.

II. ZOLOFT’S LACKLUSTER EFFICACY DATA

32. Pfizer has known, since long before Zoloft was ever approved by the FDA, that

Zoloft had an efficacy problem. In a March 8, 1984 memorandum,6 a Pfizer employee,

discussing a Zoloft efficacy report that needed to be submitted to the FDA, stated that the data

“are not in favor of sertraline as the placebo group has the most beneficial response in all of these

instances. As for the HAM-D [a depression rating scale used in clinical trials to measure

changes in depression] . . . placebo still seems to be the most effective group in this subset of

patients[.]”

33. Most of the early Zoloft efficacy studies proved to be negative, failed, or were

neutral. In the majority of the efficacy studies, there was no clinically or statistically significant

difference between Zoloft and placebo in relieving depression. In some studies, placebo actually

outperformed Zoloft in treating depression. In other studies, Zoloft was shown to be less

effective at treating depression than non-drug therapies such as St. John’s wort or daily exercise.

34. It was because of Zoloft’s lackluster efficacy data that Pfizer had substantial

difficulty in gaining approval from European regulators. In an April 18, 1991 memorandum, a

Pfizer employee expressed “serious concerns regarding the approval of sertraline in key

European countries.” According to another memorandum dated April 11, 1991, Pfizer “received

an unfavorable review in a number of countries. The common key issue is that regulators are not

convinced of sertraline’s efficacy versus placebo.” Pfizer recognized that an “analyses of

[placebo controlled U.S. studies] strongly indicate that they are not highly convincing of

sertraline efficacy versus placebo and will not provide the strong database required to overcome

regulatory obstacles.” Pfizer, therefore, decided to create a “strongly positive, placebo controlled

6 All internal Pfizer documents referenced herein were produced in prior litigation and were

thereafter unsealed.


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study . . . to ensure regulatory success.” This was to be accomplished by designing a study “to

enhance the probability of success drawing on the knowledge gained from past trials[.]”

35. In the United Kingdom (“UK”), Pfizer improperly sought help in obtaining

approval of sertraline (known as “Lustral”) in the UK from a consultant to the regulators

reviewing Zoloft, Dr. Stuart Montgomery. According to an April 24, 1989 memorandum, Dr.

Montgomery told Pfizer he would remain a “disinterested party” at the U.K. Regulatory Agency

until Pfizer appealed any negative decision and, thereafter, “he would be happy to act as an

advisor to Pfizer and declare an interest.” In addition, according to a memorandum dated April

26, 1989, Dr. Montgomery provided Pfizer with inside information that the UK regulators’

decision on Zoloft was “borderline” at that time and that the company “should be wary of

providing them with efficacy data against placebo[.]”

36. As part of Pfizer’s NDA for Zoloft, Pfizer submitted five placebo-controlled

trials.7 These studies included: Study 101, Study 103, Study 104, Study 310, and Study 315.

37. Of the five studies submitted in support of Zoloft’s efficacy, Studies 101, 310, and

315 were either negative or failed trials, Study 104 was statistically positive, and Study 103 was

mixed. None of the studies, however, showed Zoloft to be clinically effective.

38. In Study 101, placebo outperformed Zoloft in treating depression, albeit not to a

statistically significant degree. On average, patients taking placebo experienced an additional

3.5 point increase on the Hamilton Rating Scale for Depression (“HAM-D”)8 scale compared to

those taking 50mg, 100mg, 200mg, and 400mg doses of Zoloft.

7 In addition to the five efficacy trials examined by the FDA, Pfizer submitted the data from a

relapse prevention trial they had conducted—Study 320. Relapse prevention trials are not designed to establish initial efficacy and are not required for drug approval. They are intended to evaluate the benefit of continuing patients on the medication after an initial positive response. In study 320, all patients were given Zoloft for eight weeks, with no placebo control group. Those who responded were then either kept on Zoloft or switched to placebo. The purpose was to compare the rate of relapse on Zoloft to that on placebo, following an initial positive response to Zoloft. FDA evaluators expressed grave concerns about the methodology of this trial and concluded that it did not provide support for the long term efficacy of Zoloft.

8 The HAM-D scale is a multiple item questionnaire used to measure a person’s perception of depression. It is usually composed of 17-29 questions where the patient rates specific areas on a 0-5 point scale. A person’s HAM-D scale rating can be anywhere between 0-70 depending on the scale used.


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39. In Study 310, placebo again outperformed Zoloft. The benefit in HAM-D scores

of placebo patients over Zoloft-treated patients was on average 0.8 points.

40. In Study 315, Pfizer evaluated the effect of amitriptyline (Elavil), an older

antidepressant produced by Merck, as well as the effect of Zoloft. Amitriptyline was

significantly better than placebo. On average, patients taking amitriptyline outperformed

placebo on average by 3.8 points on the HAM-D scale. Zoloft, however, was not better than

placebo either statistically or clinically. The results indicated that patients taking Zoloft

outperformed placebo on average by only 1.2 points on the HAM-D scale. This difference of 1.2

points fell far short of reaching statistical or clinical significance.

41. Pooling together the data from Studies 101, 310, and 315, the three clearly

negative Zoloft trials, on average people taking placebo outperformed those taking Zoloft by

0.85 points on the HAM-D scale.

42. Study 103 had mixed results. Study 103 contained three treatment groups (50mg,

100mg, and 200mg) and one control group. Zoloft was statistically superior to placebo at the

lowest dose (50mg), with a mean difference of 2.7 HAM-D points. The results for the other

doses, however, were not statistically significant. At 100mg, the mean difference from placebo

was 2.1 points, and at 200mg, the difference was 1.5 points.9 In evaluating whether Study 103

was statistically significant, Pfizer combined the results of all the treatment groups to find a

positive outcome, a problem that was remarked upon by at least one FDA reviewer: “[Pfizer]

relied upon an analysis which combined data from these three separately randomized groups and

treated them as one group.” Thus, it is unclear if Study 103 was statistically positive since it

only provided statistically positive results for the 50mg Zoloft treatment group. However,

regardless of the mixed statistical results, the results of Study 103 failed to demonstrate clinical

significance at any dosage.

43. Study 104 was the only study that showed consistent statistically positive results

for Zoloft compared to placebo. On average, patients taking Zoloft experienced an additional 3.5

9 The pattern of findings suggests that the higher the dose, the worse the effect of Zoloft. A

similar pattern was observed in Study 310.


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point10 increase on the HAM-D scale than those taking placebo. This difference was statistically

significant, but was mixed with respect to clinical significance. The 3.5 difference barely

satisfied the criterion for clinical significance, but the overall effect size of the study was

insufficient. (Effect size is a statistical term used to measure of the size or strength of an effect.)

Thus, although Study 104 provided some evidence of Zoloft being able to statistically

outperform placebo, it is unclear if the Study 104 indicated a clear clinically superiority.

44. Pooling together the data from Study 104 and Study 103, the only two clinical

trials demonstrating at least some support for Zoloft over placebo, reveals a small treatment

effect that is below the criteria of clinical significance. The mean difference between Zoloft and

placebo in these two studies was 2.83 points on the HAM-D. Both of these metrics fall short of

meeting clinical significance.

III. THE FDA’S APPROVAL OF ZOLOFT

45. Pfizer submitted its new drug application (“NDA”) to the FDA in 1990. Pfizer

originally sought approval for Zoloft to treat depression.

46. On November 19, 1990, the Psychopharmacological Drugs Advisory Committee11

(“PDAC”) for the FDA convened to discuss Pfizer’s Zoloft NDA. The focus of the meeting was

to discuss Zoloft’s efficacy and safety. However, prior to the meeting, according to an internal

Pfizer document dated September 5, 1990, Dr. Paul Leber, Director of the FDA’s Division of

Neuropharmacological Drug Products, informed Pfizer that the he would be “solicit[ing] the

support of the Advisory Committee that the two key pivotal depression studies are adequate and

well controlled.” He pointed out problems with the studies Pfizer had submitted to prove

10 It should also be noted that a 3.5 HAM-D difference is still a rather small difference in

clinical terms. Scores on the 17 item HAM-D range from 0 to 53. A 6 point difference can be obtained merely by changes in sleep patterns, without changes in any other symptoms. Thus, even with a 3.5 point difference over placebo, these results are marginal at best.

11 The PDAC of the FDA reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the practice of psychiatry and related fields and makes appropriate recommendations to the FDA Commissioner. Recommendations from the PDAC are generally adopted by the FDA Commissioner. The PDAC is comprised of 11 voting members including the Chair that are selected by the Commissioner or designee from among authorities knowledgeable in the fields of psychopharmacology, psychiatry, epidemiology or statistics, and related specialties.


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Zoloft’s efficacy and safety, but assured Pfizer that he thought he could convince the Committee

that the studies were sufficient to recommend approval.

47. The Zoloft PDAC consisted of: Chair, Daniel E. Casey, M.D., a psychiatrist of

the Veteran’s Affairs Medical Center in Portland, Oregon; John M. Davis, M.D., a psychiatrist

of the Illinois State Psychiatric Institute; Markku I. Linnoila, M.D., PhD, the Chief of Clinical

Studies at the National Institute of Alcohol Abuse and Alcoholism; Robert F. Prien, Ph.D., the

Director of Clinical Psychopharmacology, Division of Clinical Research of National Institute of

Mental Health; Javier I. Escobar, M.Sc, M.D., a professor of psychiatry, University of

Connecticut; Jeffrey A. Liebernan, M.D.; a physician and researcher for the Long Island Jewish

Medical Center and Albert Einstein College of Medicine; Robert Mark Hammer, Ph.D., a

psychiatry and a statistics professor at the Medical College of Virginia; Linda Frances Hezel,

Ph.D., a professor of nursing at the University of California, Kansas City; Carol Ann Tamminga,

M.D., a professor of psychiatry at the University of Maryland; Paul Leber, M.D., the Director of

the FDA Division of Neuropharmacological Drug Products; and Thomas P. Laughren, M.D., a

Group Leader for Psychopharmacology at the FDA.

48. The meeting began with presentations from FDA personnel about Zoloft’s

efficacy and safety data. The efficacy data was presented by Dr. J. Hillary Lee. During the

efficacy presentation, Dr. Lee discussed Study 103 and Study 104 in detail, and presented slides

about the results of the trials. Dr. Lee expressed some concerns with Study 103 since there were

large numbers of “drop-outs” during the trial. Dr. Lee concluded her presentation by stating that

“the sponsor has provided two studies, one of which is more consistent than the other, to

demonstrate the effectiveness of Sertraline [Zoloft].”

49. Following Dr. Lee’s presentation, Dr. Ed Nevius presented a statistical review of

clinical trial data related to efficacy. Dr. Nevius pointed out that Study 103 and Study 320 had

several “problems with regard to the design of two of the studies[.]” In discussing Study 103,

Dr. Nevius commented that Pfizer had “combined data from these three separately randomized

groups and treated them as one group.” Dr. Nevius gave some general background about what


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statistical issues the FDA was looking for in evaluating Study 103 and Study 104. After Dr.

Nevius, Dr. Japobrata Choudhury presented his statistical findings regarding Study 103.

50. Next, Dr. Ryder, on behalf of Pfizer, gave a presentation. During the

presentation, in response to a declaration that the clinical evidence clearly supported efficacy, Dr.

Prien interrupted, stating:

In terms of clinical results from studies 103 and 104, we have been provided with mean change scores from baselines and the outcome of statistical analyses for the difference in mean change scores between drug and placebo. However, it is difficult to determine the clinical significance of the statistically significant differences in mean change scores, particularly when you are looking at differences in change of only 2 or 3 points on the HAM-D total score . . . which is not a tremendous difference.

51. The committee members began to engage in a discussion on the topic, but Dr.

Leber interrupted and asked the committee to wait until the presentations were completed.

Immediately before opening up the discussion to the PDAC members, Dr. Leber explained their

limited role in evaluating the Zoloft NDA:

I think you have to understand that when we face an application from a regulatory perspective, we are asked to face what the law requires us to do . . . We are required to approve the drug unless we find that the tests submitted failed to contain substantial evidence of efficacy. That means more than one investigation which is adequate and well controlled which would allow experts — experts by experience, training and background — to reach a conclusion that the drug is effective.

52. Throughout the discussion, various committee members raised serious concerns

about Zoloft’s efficacy. In fact, nearly the entire discussion centered on whether Zoloft was

proven to be effective in treating depression. When the PDAC members asked what they should

consider as proof of efficacy, Dr. Leber explained that he had “no idea what constitutes proof of

efficacy, except on the basis of what we, as a Committee, agree on an as ad hoc case as there

needs to be. You can be guided by the past but the inference is an abstraction – what is an

antidepressant?”

53. Notwithstanding, PDAC members criticized Zoloft’s efficacy data. For instance,

Dr. Hammer, a statistician, highlighted issues related to the two “positive” trials in light of the

negative ones:


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Can I toss a few statistical issues as the statistician here? In a sense, what we have is not just an effect size problem but, in a sense, what we are trying to wrestle with is sort of an intuitive multiple comparison problem. If all we had was the two out-patient studies and they fairly clearly showed some Sertraline effect, we would have what I interpret as the criteria necessary for us to say go ahead and approve the drug. That is, we have more than one well-documented study that demonstrates an effect.

So the question is how do we interpret these two positive results in the context of several more studies that fail to demonstrate that effect? I am not sure I have an answer to that but I am not sure that the law requires me to have an answer to that – fortunately or unfortunately. That would mean, in a sense, that [Pfizer] could just do studies until the cows some home until he gets two of them that are actually statistically significant by chance alone, walks them out and says that he has met the criteria.

54. Another major concern among the PDAC members was whether the observed

benefit seen in Zoloft was not just statistically significant, but also clinically significant. As Dr.

Prien explained:

In terms of the regulatory charge outlined by Paul that the sponsor provided evidence from more than one adequate study that Sertraline is effective for the treatment of depression, this group seems to agree that for outpatients we have established efficacy. I am not so sure. I would just like to throw this out because, as Paul states, there are no set boundaries, no standards for what constitutes a clinically significant difference or treatment outcome.

I am somewhat less convinced about study 103, where I believe that the differences in mean change scores between drug and placebo are marginal perhaps, at best, in looking at all the outcome criteria scales.

. . .

But I think this is something that the Committee has to deal with, that is, whether they actually think that the efficacy data are sufficient to classify it as more effective than placebo, not only statistically but clinically.

55. Dr. Hammer explained the difference between clinical and statistical significance:

With sufficient subjects, a very small difference between several groups may well be statistically significant but for the size of the affect the difference between groups may be so small as to be unimportant in terms of treatment. Suppose I were working on some sort of a drug that influenced survival in cancer patients and I could demonstrate with sufficient subjects that the drug increased life expectancy from 435 days to 435.2 days. That might be statistically significant but it would be clinically unimportant.

56. In an effort to assuage the PDAC members, Dr. Leber stated:

We are always in a position of trying to make a fair judgment, knowing that we have to weigh the requirements of the law, the expectations of a public that wants freer access to new and effective drugs, even if they are not necessarily as potent


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on a milligram basis or even in terms of the size of the treatment effect as others. They may have other advantages. It is very hard to judge a drug on a single dimension.

. . .

At the end of that, we have to go back to the regulatory charge that I raised. It is not that they are entitled to every claim, every superlative ever made, but is the application, as submitted, such that we have a right to conclude it does not have evidence of safety for use; it does not have evidence of efficacy or it is inadequately labeled. I am not counting now the chemistry requirements.

If we can reach those conclusions, we can reject the application. If we cannot reach those conclusions, you have to approve the application. That is where we are.

57. In response, Dr. Prien stated:

Let me throw this back to you, Paul. What would you do if, say, you get a statistically significant different with a difference in a HAM-D of perhaps one-tenth or three-tenths of a point; a CGI score that is just slightly different? What would you do with this, Paul? Are we going to fall back to the position that statistical significance is enough to demonstrate efficacy or are you going to leave this in the hands of a committee to try to judge whether, in their opinion, this is a clinically effective difference?

58. After a lengthy discussion, the PDAC moved to vote on whether the Pfizer had

met the minimum regulatory requirements. The PDAC voted on the question, “has the sponsor

provided evidence from more than one adequate and well-controlled clinical investigation that

supports the conclusion that Sertraline is effective for the treatment of depression[?]” The

PDAC voted six in favor, one against, with two abstaining.

59. Pfizer itself found it odd that the FDA did not question Pfizer about efficacy

despite the fact that several European regulators were troubled by the drug’s lack of efficacy.

According to a February 25, 1991 internal Pfizer email between two of its employees: “There

were no questions on efficacy . . . I find it odd that FDA not at all questioning efficacy and there

are significant questions raised by several European companies.”

60. In an August 1991 FDA memorandum obtained through the Freedom of

Information Act, Dr. Leber wrote about his recommendation that Zoloft be approved for

marketing, stating that, “[i]n recommending this action, I have considered the fact that the

evidence marshaled to support sertraline’s efficacy as an antidepressant is not as consistent or

robust as one might prefer it to be.”


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61. In another FDA memorandum, in December 1991, Dr. Leber acknowledged that

other foreign regulatory agencies were not willing to allow Zoloft marketing in their countries

due to Pfizer’s inability to prove efficacy. Dr. Leber went on to state, “I do not believe we can

successfully introduce similar, more demanding requirements domestically, at least until there is

significant ‘sea change’ in our society’s collective attitude towards Federal regulation of new

drug approvals.” Dr. Leber warned that the FDA’s approval of Zoloft was likely to be

challenged because the FDA is not “as demanding as it ought to be in regard to its standards for

establishing the efficacy of antidepressant drug products.”

IV. PFIZER ENGAGED IN MISLEADING AND DECEPTIVE MARKETING OF ZOLOFT

62. Pfizer deliberately engaged in a comprehensive scheme to prevent consumers and

doctors from knowing or appreciating Zoloft’s efficacy in treating depression by, on one hand,

suppressing any dissemination of Zoloft’s negative efficacy information while, on the other,

touting Zoloft as a very effective treatment for depression. Pfizer was able to manipulate

consumer understanding of Zoloft by presenting a one-sided and scientifically incomplete picture

of Zoloft’s efficacy and, through that unlawful and deceptive marketing, made millions on the

sale of Zoloft to California consumers.

A. The Drug Label

63. Zoloft’s drug label has never properly disclosed the clinical trial data required to

properly understand Zoloft’s efficacy in treating depression. The label lacks significant clinical

trial information that consumers and prescribing healthcare professionals would need to

determine, for themselves, if purchasing or prescribing Zoloft is worth the risks. When Zoloft

first entered the market, its product label stated:

ZOLOFT (sertraline hydrochloride) is indicated for the treatment of depression. The efficacy of ZOLOFT in the treatment of a major depressive episode was established in six to eight week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder.

64. This disclosure of efficacy data is misleading because it suggests that all clinical

trials performed on Zoloft supported efficacy when, in fact, there were at least three negative or

failed efficacy trials that indicated Zoloft could not outperform placebo.


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65. Moreover, this disclosure of efficacy data is misleading because it suggests that

numerous clinical trials support efficacy when there were, arguably, only two, at best.

66. In addition, this disclosure of efficacy data is misleading because it does not

include any information about the results of the clinical trials being referenced or indicate what

level of magnitude over placebo was observed. This lack of contextual information renders the

language a misrepresentation because it suggests a level of efficacy that is not necessarily

supported by the clinical trial data.

67. In later years, Zoloft’s label was amended several times. The most current

version reads:

The efficacy of ZOLOFT as a treatment for major depressive disorder was established in two placebo-controlled studies in adult outpatients meeting DSM-III criteria for major depressive disorder. . . . Overall, these studies demonstrated ZOLOFT to be superior to placebo on the Hamilton Depression Rating Scale and the Clinical Global Impression Severity and Improvement scales. Study 2 was not readily interpretable regarding a dose response relationship for effectiveness.

68. This disclosure of efficacy data is misleading because it does not provide any

necessary context for understanding what “Study 1” (Study 104) and “Study 2” (Study 103)

actually mean with regards to efficacy. The disclosure only states that “[o]verall, these studies

demonstrated ZOLOFT to be superior to placebo” but does not explain what that superiority was.

This language misleadingly suggests that Zoloft was substantially superior to placebo in treating

depression in these Studies, when the clinical data indicates otherwise. Indeed, there is no

mention that the results of these clinical trials were clinically insignificant.

69. In addition, this disclosure of efficacy data indicate that Study 2 “was not readily

interpretable regarding a dose response relationship for effectiveness[,]” which is misleading.

The underlying data was interpretable (and in fact was interpreted by Pfizer) as showing an

inverse relationship between dose and response, i.e., the more Zoloft people took the less

effective it was. These statements, taken as a whole, and without any mention of Zoloft’s three

negative clinical trials (Study 101, 310, and 315), are misleading because they, through the

careful omission of material information and selective disclosure of technically accurate

information, improperly imply a level of proven efficacy that is not supported by Zoloft’s


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underlying clinical data.

70. In sum, Zoloft’s drug label, as it existed in 1991 and until the present, is

inherently misleading because it does not mention or discuss the numerous clinical trials in

which Zoloft was shown to be no more effective than placebo. Moreover, the drug label fails to

disclose that the two clinical trials that supposedly demonstrated Zoloft’s efficacy were clinically

insignificant. Instead, Pfizer concocted a description which, through the artful omission of

material facts, conveys the impression that Zoloft is a very effective treatment for depression.

71. This omitted information relating to Zoloft’s efficacy should have been included

in Zoloft’s original drug label and those that followed, up to and including the current drug label.

Doctors and consumers deserve to know what Zoloft’s efficacy truly is and decide, in light of

Zoloft’s substantial negative efficacy information, whether purchasing Zoloft is worth the risks.

Absent having knowledge of Zoloft’s negative efficacy information, no reasonable consumer or

prescriber can make an informed decision about whether to purchase or prescribe Zoloft for

depression. In other words, by omitting this material information, Pfizer has robbed consumers

and prescribing healthcare professionals of having sufficient information to properly decide

whether to purchase or prescribe Zoloft.

72. Requiring the disclosure of negative efficacy information on a label has been

endorsed by the FDA. The omission of negative trial data is material since physicians need to

evaluate the positive data in relation to the negative data in weighing whether the prescription is

suitable for a patient. As Dr. Leber stated in a memorandum to the Department of Health and

Human Services regarding the disclosure of negative trials associated with the antidepressant

Celexa (generically known as citalopram)12:

One aspect of the labeling deserves special mention. The Clinical Efficacy Trials subsection within the Clinical Pharmacology section not only describes the clinical trials providing evidence of citalopram’s antidepressant effects, but makes mention of adequate and well controlled clinical studies that failed to do so. I am mindful, based on prior discussions of the issue, that the Office Director is inclined toward the view that the provision of such information is of no practical value to either the patient or prescriber. I disagree. I believe it is useful for the prescriber, patient, and 3rd party payer to know, without having to gain access to

12 Celexa was approved by the FDA in 1998 and its label includes a limited discussion of

Celexa’s negative efficacy information.


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official FDA review documents, that citalopram’s antidepressants effects were not detected in every controlled clinical trial intended to demonstrate those effects. I am aware that clinical studies often fail to document the efficacy of effective drugs, but I doubt the public, or even the majority of medical community, are aware of this fact. I am persuaded they not only have a right to know, but should know. Moreover, I believe that labeling that selectively describes positive studies and excludes mention of negative ones can be viewed as being potentially “false and misleading.”

73. Upon information and belief, since the initial approval of Zoloft in 1990, Pfizer

has conducted at least a dozen placebo-controlled clinical trials which have failed to demonstrate

that Zoloft was able to outperform placebo in the treatment of depression. The Zoloft label has

never included any discussion of any of these numerous post-approval studies, again leaving

consumers in the dark about Zoloft’s lackluster efficacy data.

B. Selective Publication of Clinical Trial Data

74. Pfizer’s deceptive drug label, however, is just one component of a larger

marketing scheme designed to mislead consumers and healthcare professionals about Zoloft’s

likelihood of efficacy. Specifically, Pfizer has engaged in selective and biased publication of

Zoloft’s clinical trials with the aim of promoting favorable studies and suppressing negative

ones. Dr. Marcia Angell, the former editor of the New England Journal of Medicine and

currently a senior lecturer in the department of social medicine at Harvard Medical School, has

commented that “[m]any drugs that are assumed to be effective are probably little better than

placebos, but there is no way to know because negative results are hidden.” Marcia Angell,

Drug Companies & Doctors: A Story of Corruption, N.Y. REV. OF BOOKS, (January 15, 2009)

available at http://www.nybooks.com/articles/archives/2009/jan/15/drug-companies-doctorsa-

story-of-corruption/.

75. Pfizer was able to prevent the disclosure of unfavorable clinical results by making

supposedly “un-biased” researchers agree to non-disclosure agreements and prevent the

publication of any clinical data without first gaining express permission. In addition, Pfizer

would expressly prohibit researchers from having access to underlying raw data to limit their

ability to question, or challenge, the reported results. Then, if a researcher’s clinical trial

ultimately demonstrated a lack of efficacy, Pfizer would place the researcher on a “do-not-use-

in-the-future” list.


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76. Selective publication of clinical trial data allows Pfizer to promote its drug in a

scientific vacuum. Since the only data available to consumers and prescribers are positive, the

perceived efficacy of Zoloft is one-sided and overstated. A study published in the New England

Journal of Medicine exposed this practice. See Erick H. Turner, et al., Selective Publication of

Antidepressant Trials and Its Influence on Apparent Efficacy, 358 NEW ENG. J. MED. 252, 252-

60 (2008). The study found “a bias toward the publication of positive results” and that a survey

of published literature indicates that ninety-four (94) percent of clinical trial studies were

positive, whereas only fifty-one (51) percent of the studies actually submitted to the FDA were

positive. The authors state that “[s]elective reporting deprives researchers of the accurate data

they need to estimate effect size realistically” and that, by “altering the apparent risk-benefit ratio

of drugs, selective publication can lead doctors to make inappropriate prescribing decisions that

may not be in the best interest of their patients and, thus, the public health.” More importantly,

an estimate of how much the impression of each drug’s effectiveness was inflated by not

publishing unfavorable studies revealed that Zoloft was the second to worst drug of those

evaluated, with an estimated 64% inflated efficacy.

77. Several of the most prestigious medical journals in the world, including the New

England Journal of Medicine, the Lancet, and the Journal of the American Medical Association,

recognized the problem of pharmaceutical control over study design and publication:

We are concerned that the current intellectual environment in which some clinical research is conceived, study subjects are recruited, and the data are analyzed and reported (or not reported) may threaten this precious objectivity.

[C]corporate sponsors have been able to dictate the terms of participation in the trial – terms that are not always in the best interests of academic investigators, the study participants, or the advancement of science generally.

Investigators may have little or no input into trial design, no access to the raw data, and limited participation in data interpretation. These terms are draconian for self-respecting scientists, but many have accepted them because they know that if they do not, the sponsor will find someone else who will.

Editorial, Sponsorship, Authorship, and Accountability, 345 NEW ENGL. J. MED. 825-27 (2001).

C. Pfizer’s Ghostwriting Program

78. The clinical peer-review process is an integral component of the medical research


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field and pharmaceutical development. It allows new ideas and theories to be tested against the

critical eye of fellow researchers and ferrets out otherwise unfeasible approaches or products.

Doctors rely heavily on published papers and the peer review process to gain insight into new

and potentially life-saving advances in medicine, as well as to learn about potential dangers that

were previously unknown. See Puneet Manchanda & Elizabeth Honka, The Effects and Role of

Direct-to-Physician Marketing in the Pharmaceutical Industry: An Integrative Review, 5 YALE J.

HEALTH POL’Y L. & ETHICS 785, 796 (2005). In addition, the FDA and other regulatory bodies

rely on the intellectual rigor and transparency attendant to the peer review process to keep

apprised of important issues that fall within their regulatory jurisdiction. The success of this

system is predicated on integrity and transparency. Doctors, regulatory officials, researchers,

and even consumers make important healthcare and research decisions based on the belief that

these studies are unbiased and accurate.

79. Pfizer understood that the best way to ensure the success of Zoloft was to

convince the scientific and medical community that Zoloft was safe and effective by cultivating a

body of “peer-reviewed research” to enhance Zoloft’s credibility. To that end, Pfizer created a

large-scale ghostwriting program. Pfizer would author, or have a medical communications

company author, a study specifically designed to promote a marketing message, i.e., Zoloft’s

efficacy. Then, Pfizer would pay “key opinion leaders” (“KOLs”) to put their names on the

article and get the article published in specifically targeted medical journals. When the article

appeared in the journal, there would be no indication of Pfizer’s involvement.

80. Pfizer had an entire team devoted to the publication of positive medical journal

articles about Zoloft. In addition, Pfizer worked with outside medical ghostwriting vendors to

create a steady stream of Zoloft-positive medical journal articles.

81. Dr. David Healy, a psychopharmacologist and professor at the University of

Wales College of Medicine, and a colleague conducted an analysis of Zoloft articles that were

“coordinated” by a medical communications company called Current Medical Direction

(“CMD”). Pfizer had hired CMD to promote Zoloft in the 1990s. David Healy & Dinah Cattell,

Interface Between Authorship, Industry and Science in the Domain of Therapeutics, 183 BRITISH


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J. OF PSYCH. 22-27 (2003). According to the study, CMD coordinated over 85 medical journal

articles about Zoloft during a three-year period. By early 2001, 55 of these articles had been

published in journals such as the New England Journal of Medicine, Journal of the American

Medical Association (JAMA), Archives of General Psychiatry and the American Journal of

Psychiatry. Interestingly, all of the clinical trial results were favorable to Zoloft. The analysis

found that “the CMD-linked articles report[ed] universally positive results” and that there were

“significant discrepancies between published data and the raw data from the actual clinical

trials.” Most of the 85 articles appeared to have been authored by CMD and, in a number of

instances, the authors were listed in Pfizer internal memos as “TBD” (i.e., “to be determined”).

The study concluded that:

The combination of distinguished journal, distinguished author, an efficient distribution system and sponsored platforms appears to have led to an impact on the therapeutics domain greatly in excess of 50% of the impact of the rest of the literature on sertraline. The impact of this literature on third-party payers and other interested parties is at present unquantifiable. The question of literature impact would seem to be tied closely to the nature of ghostwriting. Authorship lines from perceived opinion-leaders with minimal company representation and non-declaration of other non-academic authorship inputs increase the likelihood that these articles will be influential with prescribers and purchasers.

82. Corroborating the study’s finding, an internal company document shows that

CMD kept a “Zoloft publications scorecard” for Pfizer which contained a running list of in-

progress medical journal articles with details of the status, the names of the designated authors

(KOLs or “thought leaders” in their respective fields), and the ghostwriting vendor to be used.

83. An internal PowerPoint presentation prepared by Pfizer in 2000 states that the

purpose of the publications program was to, among other things, “promote efficacy[,]”

“[h]ighlight drug’s superiority to a competitor(s)[,]” “[l]everage good will with academic

investigators[,]” “[i]ncrease media and public perception of the drug and Pfizer[,]” and

“[p]rovide tools for sales force to drive prescriptions based on data[.]” The PowerPoint explains

that the “bottom line” in publication projects is to “optimize our ability to sell Zoloft[.]”

D. Paid-For Opinions and Conflicts of Interest

84. Studies have demonstrated that “[a]uthors who had financial relationships with

pharmaceutical companies were significantly more likely to reach supportive conclusions than


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authors without such industry affiliations” and “reports suggest that industry may alter, obstruct,

or even stop publication of negative studies.” Scope and Impact of Financial Conflicts of

Interest in Biomedical Research, 342 NEW ENGL. J. MED. 1539-44 (2000).

85. One of the most powerful methods employed by Pfizer to promote Zoloft’s

efficacy was directly paying KOLs to declare their support for Zoloft and concealing Pfizer’s

financial relationship with KOLs. In one internal Pfizer memorandum from 1995, a Pfizer

employee stated: “With regards to the authors, we want to avoid a list of Pfizer names. One is

acceptable as a study coordinator, the rest should be investigators who will be of benefit to the

launch of Zoloft[.]” Pfizer deliberately concealed various doctors’ financial relationships with

Pfizer so they would have more credibility in touting Zoloft when it went to market.

86. Dr. Marcia Angell, in reviewing a book about how conflicts of interest impact

drug development, explains that “highly influential faculty physicians – referred to by the

industry as ‘thought-leaders’ or ‘key opinion leaders’ (KOLs) . . . write textbooks and medical

journal papers, issue practice guidelines (treatment recommendations), sit on FDA and other

governmental advisory panels, head professional societies, and speak at the innumerable

meetings and dinners that take place every year to teach clinicians about prescription drugs ...”

Marcia Angell, Drug Companies & Doctors: A Story of Corruption, N.Y. Rev. of Books,

(January 15, 2009) available at http://www.nybooks.com/articles/archives/2009/jan/15/drug-

companies-doctorsa-story-of-corruption/. Dr. Angell explains that “[c]onflicts of interest affect

more than research. They also directly shape the way medicine is practiced, through their

influence on practice guidelines issued by professional and governmental bodies, and through

their effects on FDA decisions[.]”

E. Zoloft’s Massive Efficacy Promotion Campaign

87. After Pfizer was approved in 1991, Pfizer embarked on a massive campaign to

promote Zoloft as an effective and reliable treatment for depression.

88. The first arm of this campaign involved the “direct-to-prescriber” approach.

Pfizer would “wine and dine” prescribing healthcare professionals to encourage them to

prescribe Zoloft. Pfizer would pay prescribing healthcare professionals to attend various events,


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such as theater shows, sporting events, and ski trips and pay for stays at luxurious hotels and

meals at fancy restaurants.

89. Pfizer also used a large sales force, long recognized as the largest sales force in

the industry, to visit prescribing healthcare professionals on a routine basis to promote Zoloft.

These sales representatives, who were typically young attractive people, would visit prescribing

healthcare professionals and “brief” them on how effective Zoloft was at treating depression.

Notably absent from any of Pfizer’s promotion to prescribers was any disclosure of Zoloft’s

negative efficacy data. Instead, sales representatives would leave behind free samples and

various forms of product literature, all designed to give prescribing healthcare professionals the

one-sided and warped impression that Zoloft’s efficacy was absolute.13

90. The second arm of Pfizer’s promotional campaign focused on media

advertisements to prescribing healthcare professionals and consumers. These print and video

advertisements gave the false and misleading impression that Zoloft was a tremendously

effective drug for the treatment of depression.

91. For example, in a 2005 medical journal, Pfizer published an advertisement

directed toward prescribing healthcare professionals which read:

Zo effective

Zo well tolerated

Zo trusted

Zoloft

Choose the #1 prescribed SSRI

92. The advertisement states that Zoloft is “Zo Effective[.]” This is a

misrepresentation because “Zo” is used in place of “So,” which is defined in terms such as “to a

great extent,” “very or extremely,” and “without any doubt.” Thus, Pfizer’s advertisement

13 Pfizer’s willingness to engage in illegal conduct with regard to the promotion of drugs

directly to prescribers is well documented. For instance, in 2009, Pfizer agreed to pay $2.3 billion dollars to settle government claims that the company aggressively promoted a number of its drugs, including Zoloft, for unapproved uses. See LeAnne Gendreau, Pfizer to Announce Record $2.3 B Settlement, Associated Press, Sept. 2, 2009 (“The company aggressively promoted drugs for unapproved, off label uses, bribed medical professionals with cash and gifts and used thinly disguised kickbacks to hawk its products.”).


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suggests that Zoloft is extremely effective, that most depressed patients will benefit from using

Zoloft and there is no doubting its efficacy. This is false and misleading in light of the actual

clinical trial data. There is substantial clinical trial data that undermines this assertion.

93. In another advertisement, Pfizer claims “Zoloft has helped millions with

depression.” In comic strip format, the advertisement tells a story about “Denise” who, depicted

as a balloon-cartoon, is a music conductor that felt “an octave lower” because she “was

depressed” and “had to do something about it.” However, before she went to the doctor, she “did

some homework” and discovered that “Zoloft is the number one prescribed brand for

depression[.]” So, Denise went to her doctor and he told her “it’s helped millions” just like

Denise. In the next box, Denise “realize[s] that Zoloft was helping me at work and at home.”

Beneath the comic strip, the ad states: “Denise took comfort in the fact that Zoloft has helped so

many people for so many years. Zoloft is safe and effective. It has treated more people with

more types of depression and anxiety than any brand of its kind. So she asked her doctor about

Zoloft. Zoloft. #1 for millions of reasons.”

94. In another comic-strip advertisement, a mother named Kathy is told by her

daughter that “Mommy, you’re no fun anymore” which makes Kathy realize “It was time to get

help.” Kathy subsequently goes online to conduct research about Zoloft. Kathy subsequently

speaks to her doctor about Zoloft and he writes a prescription. Soon after, Kathy notices a

difference, “and so did [her] family.” At the bottom of the advertisement it reads, “Kathy

researched all the medications. She found out that ZOLOFT has helped millions with depression

and anxiety. ZOLOFT is safe and effective. It has treated more people with more types of

depression and anxiety than any brand name of its kind. So she asked her doctor about

ZOLOFT.”

95. These comic-strip advertisements are misleading because they state, without any

qualification or contextual information, that Zoloft is “safe and effective” even though there is

substantial clinical data militating against this assertion.14 This language misrepresents the data

14 In addition, both of these advertisements prompt consumers to go online and research

Zoloft to learn about the drug. Pfizer was fully aware that Zoloft’s negative clinical trial data would not be available, and that patients would not be able to learn about the full scope of


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supporting Zoloft’s efficacy. This statement is also misleading because it suggests that Zoloft is

always effective in all patients, when the clinical trial data suggests that is not true. This

deceptive language is further supported by language indicating that Zoloft has helped millions

with depression. This assertion is misleading because it does not disclose that much (if not all)

of that population of patients would have also responded to placebo, as was demonstrated in

clinical trials. This advertisement makes Zoloft seem like the best possible antidepressant

despite substantial clinical trial data suggesting that Zoloft is, at best, marginally better than a

placebo.

96. The combination of direct-to-prescriber and direct-to-consumer promotion

convinced consumers and prescribing healthcare professionals that Zoloft was particularly

effective at treating depression. Pfizer’s promotion, however, never revealed that the majority of

clinical trials showed that Zoloft was not able to statistically or clinically outperform placebo.

V. SPECIFIC OMISSIONS

97. On information and belief, Pfizer made numerous material omissions in is

promotion and advertising for Zoloft, some of which include:

a. On Zoloft’s label, Pfizer did not disclose that five placebo-controlled efficacy

trials were submitted to the FDA to prove that Zoloft was effective for treating

depression, but only two showed that Zoloft would statistically outperform

placebo in treating depression.

b. Pfizer did not mention or describe negative Studies 101, 310, or 315 in any

capacity on the Zoloft drug label.

c. Pfizer did not provide the results of Studies 101, 310, or 315 on the Zoloft drug

label in any capacity, including failing to disclose whether Studies 101, 310, or

315 were negative or failed, or whether the results observed between Zoloft and

Zoloft’s efficacy. Pfizer, instead, created many sources of positive information about Zoloft’s efficacy aimed at directing patients to ask their doctors for Zoloft, without any meaningful understanding of Zoloft’s ability outperform placebo in treating depression. This is just another example of Pfizer using deceptive advertising to promote Zoloft’s efficacy while suppressing the disclosure of any negative information.


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placebo were statistically or clinically significant.

d. Pfizer did not disclose the difference observed between Zoloft and placebo in

treating depression in Studies 104 or 103 on the Zoloft Label.

e. Pfizer did not disclose whether the observed statistical superiority of Zoloft over

placebo as observed in Studies 104 or 103 was clinically significant on the Zoloft

label.

f. Pfizer did not disclose any meta-analysis about Zoloft and its ability to

outperform placebo on the Zoloft label.

g. Pfizer did not provide any data, or indicate that such data does not exist, on the

Zoloft label indicating whether Zoloft was able to outperform placebo in treating

moderate to mild depression.

h. Pfizer never published or attempted to publish the results of Studies 101, 310, or

315 in any academic journal.

i. Pfizer never made the results of Studies 101, 310, or 315 available to consumers

or prescribers on www.Pfizer.com or www.Zoloft.com.

j. Pfizer never provided copies of Studies 101, 310, or 315 to prescribers in its

pharmaceutical detailing efforts by pharmaceutical representatives.

k. Pfizer never provided copies of Studies 101, 310, or 315 to prescribers at various

continuing education seminars produced by Pfizer, where Zoloft was discussed as

a treatment option for depression.

l. Pfizer never referenced, described, or disclosed the results of Studies 101, 310, or

315 to prescribers in the form of “Dear Doctor” letters, or other direct-to-

prescriber communications.

m. Pfizer never discussed or mentioned Studies 101, 310, or 315 in advertisements

promoting Zoloft for use in treating depression.

n. Pfizer never disclosed whether there was any data supporting the use of Zoloft in

treating mild or moderate depression in any advertisements.

o. Pfizer never disclosed to patients that much of the effect observed from taking


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Zoloft to treat depression could be duplicated with a placebo.

p. Pfizer never disclosed to patients that Zoloft’s efficacy was only observed, in the

context of clinical trial data, in patients suffering from severe depression.

VI. PLAINTIFF-SPECIFIC ALLEGATIONS

98. Prior to March 18, 2005, Plaintiff Laura A. Plumlee saw an ad promoting Zoloft’s

efficacy for depression. (See paragraphs 154-155 below). On or about March 18, 2005, Plaintiff

was prescribed a fifty (50) mg daily dose of Zoloft by her psychiatrist to treat ongoing

depression. Prior to starting the prescription, Plaintiff read and relied upon Zoloft’s label. In later

years, her dosage was increased to one hundred (100) mg, then two hundred (200) mg, and then

to four hundred (400) mg per day. The maximum recommend daily dose of Zoloft is 200 mg.

99. Plaintiff continued to purchase and ingest Zoloft until shortly after Pfizer’s patent

over Zoloft expired in June 2006. Plaintiff last purchased brand name Zoloft on or about August

11, 2006. Thereafter, Plaintiff purchased the generic version of Zoloft, sertraline, until on or

about June 2008.

100. In total, between March 18, 2005, and August 11, 2006, Plaintiff spent

approximately $171 of her own money to purchase Zoloft and, with insurance payments, Pfizer

received approximately $3,727.10.

101. During the period in which Plaintiff was purchasing and ingesting Zoloft, Plaintiff

did not know that Zoloft’s drug label and advertising were deceptive or that they lacked material

information about the drug’s efficacy.

102. During the period Plaintiff was purchasing and ingesting Zoloft, Plaintiff was

never informed, nor did Plaintiff read or see, any information about Zoloft’s negative efficacy

trials or that, in a majority of Zoloft’s placebo-controlled efficacy trials, Zoloft failed to

statistically and clinically outperform placebo. Likewise, Pfizer did not convey any of the

negative efficacy results in their pre- or post-approval Zoloft clinical trials to Plaintiff, her

physicians, or the public in general.

103. Plaintiff did not believe that Zoloft was helping her depression. She continued to

purchase and ingest Zoloft for three years, always hoping that the drug would eventually take


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root and begin to help manage her depression. After three years, however, she gave up. Plaintiff

did not know that Zoloft had issues with efficacy in its clinical trials. Based on the Zoloft label

she had reviewed, Plaintiff had no reason to doubt that Zoloft was demonstrated to be superior to

placebo, particularly since no mention of any negative clinical trials appears on the label or any

of Zoloft’s marketing materials. Plaintiff believed that Zoloft simply did not work for her

because “sometimes drugs just do not work for some people.” Plaintiff was unaware that she was

deprived of material information when she first purchased Zoloft. Plaintiff was unaware that she

had been the victim of a consumer protection violation.

104. Between March 2008 and May 2012, Plaintiff did not see any media, journal

articles, press releases, websites, letters, or statements concerning Zoloft and its ability to

outperform placebo in treating depression. Upon information and belief, no media or information

criticizing Zoloft’s efficacy existed during this time period to which a reasonably diligent

consumer would have been exposed.

105. Between March 2008 and early 2012, Plaintiff had no reason to believe she was

the victim of consumer protection violations or that her purchase of Zoloft was made without

material information about the drug.

106. Between March 2008 and early 2012, Plaintiff did not know that she had been

deprived of material information or that the Zoloft label and advertising was misleading in any

particular.

107. Between March 2008 and February 2012, information about Zoloft’s negative

efficacy data was not available to the lay public, since neither Pfizer nor the FDA published or

publicized Zoloft’s negative clinical trials. In the absence of a publicized law enforcement or

media investigation, some specific motivating event, or full and fair disclosure by the

manufacturer, a reasonably diligent consumer could not have been aware of unpublished clinical

trials, such as the ones that support Plaintiff’s claims in this action – many of which were

obtained only in conjunction with this lawsuit. In addition, Plaintiff did not have access to any

academic journals containing articles about antidepressant efficacy and the placebo effect

generally. The existence of academic articles on antidepressant efficacy and the placebo effect


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could not put a reasonable consumer on notice of potential misrepresentations because, inter

alia, most laypeople do not have subscriptions to academic journals. A subscription to a single

journal can cost thousands of dollars. Moreover, Plaintiff had no reason to suspect that she had

been the victim of a consumer protection violation. Nothing in the course of her treatment

provided her any impetus to suspect Pfizer’s foul play.

108. On or about May 22, 2012, Plaintiff watched a 60 Minutes segment that first aired

on February 19, 2012, regarding the placebo effect and depression. See

http://www.cbsnews.com/news/treating-depression-is-there-a-placebo-effect/. During the 13:44

segment, correspondent Lesley Stahl begins by interviewing Dr. Irving Kirsch, Associate

Director of the Placebo Studies Program at Harvard Medical School, and expresses surprise to

learn the extent to which Kirsch’s research has revealed that the chemicals in anti-depressant

drugs have little or no effect on the treatment outcome of most patients suffering depression.

Through additional guests, Stahl’s segment introduces the “low bar” set by FDA approval. Dr.

Michael Thase, identified as one of the defenders of anti-depressant manufacturers, concedes that

the vast majority of clinical outcomes of patients are due to the placebo effect. (“I wish our

antidepressants were stronger. I hope we have better ones in the future.”) Dr. Walter Brown of

Brown University Medical School, commented on Stahl’s reporting of the billions of dollars

spent advertising antidepressants: “There’s a lot of hype out there.” Finally, exploring that only

two positive studies are required by the FDA and that drug companies often do not publish the

negative efficacy studies, Dr. Tim Kendall, co-director of the Great Britain National Health

Service commission that was charged to review the antidepressant clinical data, states, “What

characterizes the unpublished [studies] is that they're negative. Now I don't think it's that their

method is somehow wrong; it's that their outcome is not suitable from the company's point of

view.”

109. After watching this 60 Minutes segment, Plaintiff grew concerned about her

previous purchases of Zoloft. She retained counsel in June 2012. Shortly thereafter, as a result of

her then-attorneys’ investigation, Plaintiff learned, for the first time, that Pfizer had misled her

by failing to disclose important negative clinical trial data regarding Zoloft's efficacy. Given the


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risk of the serious and well-documented side effects associated with Zoloft, Plaintiff would never

have purchased Zoloft if this information had been made known to her. Plaintiff relied on the

sufficiency and accuracy of Pfizer’s advertisements and Zoloft’s drug label in making her

decision to purchase and ingest Zoloft to treat her depression.

110. On January 31, 2013, Plaintiff filed suit.

111. Upon information and belief, Plaintiff’s prescriber was never informed about

Zoloft’s negative efficacy information and never relayed any information to the Plaintiff about

Zoloft’s inability, statistically or clinically, to outperform placebo.

112. Information about Zoloft’s performance against placebo in treating depression is

information that a reasonable consumer and prescriber would consider important in making a

purchasing and prescribing decision.

113. Upon information and belief, Plaintiff and her prescriber consider information

about Zoloft’s performance against placebo important in their decision-making process.

CONSUMER CLASS ALLEGATIONS

114. This matter is brought by Plaintiff on behalf of herself and those similarly

situated. As discussed at length in this First Amended Complaint, Pfizer deliberately withheld

and actively concealed material information about Zoloft’s performance against placebo from

consumers. Pfizer’s misleading and deceptive marketing of Zoloft was directed toward every

consumer and prescribing healthcare professional in the State of California. Moreover, the

deceptive conduct directed at California consumers and prescribing healthcare professionals was

uniform—the same misleading drug label, advertisements, and material omissions were directed

at every California citizen who purchased Zoloft. Accordingly, in light of Pfizer’s deceptive

marketing / material omissions related to Zoloft’s efficacy data, Plaintiff brings a consumer

protection cause of action against Pfizer on behalf of herself and those similarly situated

California Consumers.

115. The California Consumer Class is defined as follows:

All persons within the State of California who purchased and/or paid for Zoloft manufactured and/or distributed and/or marketed by Pfizer from December 30, 1991 (the launch date of Zoloft) until the present for the treatment of depression,


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and who are not seeking a personal injury claim against Pfizer related to Zoloft (“California Consumer Class”).

116. Pfizer’s failure to disclose information about Zoloft’s negative clinical trials and

failure to disclose that, in the two trials in which Zoloft “outperformed” placebo, the effect was

marginal or very limited were material omissions. Accordingly, failure to properly present these

material facts to California consumers (the California Consumer Class) and prescribing

healthcare professionals robbed them of being able to make an informed decision about

purchasing or prescribing Zoloft.

117. Plaintiff brings Count I against Pfizer, on behalf of herself, and all those similarly

situated, pursuant to Federal Rule of Civil Procedure 23.

118. The California Consumer Class is properly brought and should be maintained as a

class action under Rule 23(a), satisfying the class action prerequisites of tuberosity,

commonality, typicality, and adequacy because:

a. Numerosity: Individual joinder of the California Consumer Class members

would be wholly impracticable. Millions of Zoloft prescriptions have been filled

in the State of California by millions of consumers.

b. Commonality: Questions of law and fact are common to all members of the

California Consumer Class. Pfizer’s misconduct was uniformly directed at all

consumers and their prescribing healthcare professionals in California through the

use of a misleading drug label. Thus, all members of the California Consumer

Class have a common cause of action, here Counts II, III, and IV, against Pfizer,

which involve common issues of fact and law applicable to all California

Consumer Class members.

c. Typicality: Plaintiff’s claims are typical of the claims of the California

Consumer Class, because her claims arise from the same course of conduct by

Pfizer, i.e., deceptive and unlawful marketing practices related to Zoloft. Plaintiff

is a typical class representative because, like all members of the California

Consumer Class, she purchased Zoloft in California and the Zoloft that was sold

was unfairly, deceptively and unlawfully marketed to consumers within


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California.

d. Adequacy: Plaintiff will fairly and adequately represent and protect the interests

of the California Consumer Class. Her consumer protection claims are common

to all members of the California Consumer Class and she has a strong interest in

vindicating her rights. In addition, Plaintiff and the California Consumer Class

are represented by counsel who is competent and experienced in both consumer

protection and class action litigation.

119. The California Consumer Class is properly brought and should be maintained as a

class action under Rule 23(b) because a class action in this context is superior.

120. Pursuant to Rule 23(b)(3), common issues of law and fact predominate over any

questions affecting only individual members of the California Consumer Class. Pfizer

deliberately concealed material facts about Zoloft’s efficacy, and in so doing, deprived all

California consumers of making an informed decision to purchase a prescription drug. In

addition, proceeding with a California Consumer Class action is superior to other methods for

fair and efficient adjudication of this controversy because, inter alia,:

a. Individual joinder of the individual members is wholly impracticable;

b. The economic damages suffered by the individual members may be relatively

modest compared to the expense and burden of individual litigation;

c. The court system would benefit from a class action because individual litigation

would overload court dockets and magnify the delay and expense to all parties;

d. The class action device presents far fewer management difficulties and provides

the benefit of comprehensive supervision by a single court with economies of

scale.

121. Rules 23(b)(1) and (2) contemplate a class action for purposes of seeking class-

wide injunctive relief. Here, Pfizer has engaged in conduct that has resulted in misleading

consumers and prescribing healthcare professionals about Zoloft’s efficacy. Since Pfizer’s

conduct has been uniformly directed at all consumers and prescribing healthcare professionals in

the State of California, and the conduct continues presently, injunctive relief on a class-wide


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basis is a viable and suitable solution to remedy Pfizer’s continuing misconduct.

122. With regard to Rule 23(b)(1)(A), resolution of the issues presented for injunctive

relief on an individual basis would pose a serious risk of requiring Pfizer to follow inconsistent

courses of continuing conduct. One court could determine that the Zoloft drug label was

partially misleading and order Pfizer to take specific action. Another court could also determine

that Zoloft’s drug label was defective but order a conflicting course of conduct. If the issues

presented for this class-wide injunctive relief are not dealt with by a single court, there is a very

real possibility that Pfizer would be subjected to an inescapable legal quagmire of not being able

to comply with one judgment without violating terms of another.

123. With regard to Rule 23(b)(2), Plaintiff seeks injunctive relief on behalf of the

members on grounds generally applicable to the entire California Consumer Class. Certification

under Rule 23(b)(2) is appropriate because Pfizer has acted or refused to act on grounds that

apply generally to the California Consumer Class, i.e., Pfizer has marketed the same Zoloft using

the same misleading drug label and advertisements to all the class members. Any final

injunctive or declaratory relief would benefit the entire California Consumer Class as Pfizer

would be prevented from continuing its unlawful and deceptive marketing practices and be

required to honestly disclose to consumers and prescribing healthcare professionals all material

information about Zoloft’s efficacy in treating depression.

COUNT I CALIFORNIA CONSUMERS CLASS

VIOLATIONS OF CAL. CIV. CODE §§ 1750, ET SEQ.

124. Plaintiff incorporates by reference each and every prior and subsequent allegation

of this Complaint as if fully restated here.

125. California’s Consumer Legal Remedies Act, Cal. Civ. Code §§ 1750, et seq.

makes it unlawful to engage in unfair methods of competition and unfair or deceptive acts or

practices intended to result, or which result, in the sale or lease of goods or services to any

consumer.

126. Plaintiff and the California Consumer Class were, and continue to be, at all times

material to the Complaint, “consumers” and “persons” as defined by the Cal. Civ. Code § 1761.


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Plaintiff and California Consumer Class purchased and/or paid for Zoloft for personal and/or

family and/or household use during the relevant time period.

127. As alleged throughout this Complaint, Pfizer deliberately engaged in deceptive

and unlawful marketing in violation of Civ. Code § 1770(a) by failing to disclose material

information to the Plaintiff and California Consumer Class about Zoloft’s inability to outperform

placebo in numerous clinical trials. Pfizer failed to adequately disclose material information

about Zoloft’s efficacy and, in so doing, deprived consumers of an ability to make an informed

decision.

128. Specifically, Pfizer violated the following proscribed practices pursuant to Cal.

Civ. Code § 1770(a) with the purpose of inducing Plaintiff and the California Consumer Class to

purchase and ingest Zoloft:

a. § 1770(a)(2): Pfizer represented to Plaintiff and the California Consumer Class that

Zoloft was proven to be superior to placebo in two clinical trials but failed to mention

that a large percentage of the trial group quit the trial because it lacked efficacy and

caused severe side effects. This gave a false certification of Zoloft’s efficacy because

the clinical trial results, as represented by Pfizer, were skewed and Pfizer was aware

of this problem. Moreover, omitting material information concerning the actual

results of those two clinical trials and concealing the results of numerous clinical

trials showing that Zoloft was no more effective than placebo was a false certification

of the drug’s efficacy.

b. § 1770(a)(5): Pfizer represented to Plaintiff and the California Consumer Class that

Zoloft has a specific use, benefit, or characteristic which it did not have. Omitting

material information about the actual results of two clinical trials purporting to show

Zoloft’s efficacy and concealing the results of numerous clinical trials showing that

Zoloft was no more effective than placebo constituted a misrepresentation concerning

a use, benefit, or characteristic.

c. § 1770(a)(7): Pfizer misrepresented to Plaintiff and the California Consumer Class

that Zoloft was of a particular standard, quality, or grade., i.e., substantially effective


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for the treatment of depression. In truth, Zoloft was not as effective as Zoloft’s drug

label represented, because there were numerous studies showing that Zoloft is no

more effective at treating depression than placebo. Moreover, Pfizer’s failure to

properly disclose Zoloft’s marginal benefit in treating depression, as observed in the

two clinical trials purporting to show Zoloft’s efficacy, constituted a

misrepresentation of a material standard, quality, or grade.

129. Pfizer’s concealment of numerous clinical studies showing that Zoloft was no

better than placebo, and its failure to adequately describe Zoloft’s marginal effect on depression,

was a material omission that consumers and prescribing healthcare professionals should have

known about prior to purchasing or prescribing Zoloft for the treatment of depression.

130. Plaintiff and the California Consumer Class lost money as a result of Pfizer’s

deceptive and unlawful marketing practices pursuant to Cal. Civ. Code § 1770(a), through the

purchase of Zoloft that was illegally advertised and marketed in violation of Cal. Civ. Code §

1770(a).

131. Pursuant to Cal. Civ. Code § 1782(d), Plaintiff initially filed a Complaint on

January 31, 2013, asking Pfizer to take immediate action to correct its continuing violations of

the CLRA. Pfizer, however, continues to engage in its unlawful conduct to this day. Thus,

Plaintiff’s have satisfied the pre-suit notice requirements of Cal. Civ. Code § 1782(d) and are

eligible to seek, in addition to injunctive relief, actual damages, restitution, punitive damages,

attorneys’ fees and costs, and for such other relief as set forth below.

COUNT II CALIFORNIA CONSUMERS CLASS

VIOLATIONS OF CAL. BUS. & PROF. CODE §§ 17200, ET SEQ.



133. California’s Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code §§ 17200,

et seq., protects both consumers and competitors by promoting fair competition in commercial

markets for goods and services. California’s Unfair Competition Law is interpreted broadly and

provides a cause of action for any unlawful, unfair, or fraudulent business act or practice. Any


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unlawful, unfair, or fraudulent business practice that causes injury to consumers falls within the

ambit of California’s Unfair Competition Law.

134. Pfizer engaged in substantial advertising and marketing of Zoloft within the State

of California.

135. Because of Pfizer’s unlawful, fraudulent, and unfair business practices, Plaintiff

and the California Consumer Class were misled into purchasing and using Zoloft.

I. UNLAWFUL BUSINESS PRACTICES

136. As set forth in the preceding paragraphs, Pfizer has engaged in the unlawful

business practice of misleading Plaintiff and the California Consumer Class regarding Zoloft’s

ability to outperform placebo in treating depression. Pfizer’s deceptive and unlawful marketing

practices have violated numerous California laws, including, inter alia: Cal. Civ. Code §§ 1709,

et seq. (fraudulent deceit); Cal. Civ. Code §§ 1571, et seq. (fraud); Cal. U. Com. Code §§ 2313-

15 (breach of express and implied warranty); Cal. Bus. & Prof. Code §§ 17500, et seq. (false

advertising and marketing); and Cal. Civ. Code §§ 1750, et seq. (violations of California’s

Consumer Legal Remedies Act).

137. As a result of Pfizer’s unlawful business practices, Plaintiff and the California

Consumer Class purchased Zoloft without sufficient information regarding a material aspect of

the drug. Plaintiff and the California Consumer Class reasonably relied upon Pfizer’s

misrepresentations regarding Zoloft in deciding whether to purchase and use the drug.

II. FRAUDULENT BUSINESS PRACTICES

138. As set forth in the preceding paragraphs, Pfizer has engaged in the fraudulent

business practice of misleading Plaintiff and the California Consumer Class regarding Zoloft’s

ability to outperform placebo in various clinical trials.

139. A business act or practice is “fraudulent” under California’s Unfair Competition

Law if it actually deceives or is likely to deceive members of the consuming public.

140. As set forth in the preceding paragraphs, Pfizer engaged in a comprehensive

scheme to mislead consumers and prescribing healthcare professionals regarding Zoloft’s ability

to outperform placebo in various clinical trials. Because of Pfizer’s fraudulent business


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practices, Plaintiff and the California Consumer Class were misled about Zoloft and,

accordingly, purchased Zoloft without knowing a material aspect of the drug.

III. UNFAIR BUSINESS PRACTICES

141. As set forth in the preceding paragraphs, Pfizer has engaged in an unfair business

practice of misleading Plaintiff and the California Consumer Class regarding Zoloft’s ability to

outperform placebo in treating depression.

142. A business practice is unfair when it offends an established public policy or when

the practice is immoral, unethical, oppressive, unscrupulous, or substantially injurious to

consumers.

143. Pfizer’s deceptive and unlawful marketing practices offend public policy and are

fundamentally immoral, unethical, oppressive, unscrupulous, or substantially injurious to

consumers. Pfizer’s scheme was to mislead consumers about Zoloft by hiding the majority of

clinical trials showing Zoloft does not work while overstating its efficacy. The purpose of this

conduct was to manipulate consumer understanding of Zoloft. This conduct offends any notion

of public policy and is unethical.

144. The harm to Plaintiff and the California Consumer Class caused by Pfizer’s unfair

business practices outweighs any countervailing benefits to consumers or competition, and could

not reasonably have been known and avoided by consumers. Furthermore, Pfizer’s unfair

business practices cannot be excused for any business justification, motive, or rationale in light

of the severity of Pfizer’s misconduct and the harm caused to Plaintiff and the California

Consumer Class.

145. As a result of Pfizer’s violations of the UCL, Plaintiff seeks an order of this Court

enjoining Pfizer from continuing these unlawful, fraudulent, and unfair practices and awarding

Plaintiff and the California Consumer Class, inter alia, actual damages, restitution, a

disgorgement of Pfizer’s profits, and for such other relief set forth below.

COUNT III CALIFORNIA CONSUMER CLASS

VIOLATIONS OF CAL. BUS. & PROF. CODE §§ 17500, ET SEQ.


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147. Plaintiff and the California Consumer Class bring a cause of action against Pfizer

pursuant to Cal. Bus. & Prof. Code §§ 17500, et seq. (“California’s False Advertising Law”).

148. The purpose of California’s False Advertising Law is to protect consumers from

false or misleading advertising and promotions. California’s False Advertising Law prohibits the

false or deceptive advertising of products to consumers in any form of media, when the company

placing the advertisement knows, or should have known, that the advertisement would be likely

to mislead consumers about a material aspect of a product.

149. Pfizer has used advertising on its packaging and through various media outlets to

sell and market Zoloft directly to consumers. The advertisements and labeling are deceptive,

untrue, or misleading within the meaning of the California’s False Advertising Law because they

misleading state the ability of Zoloft to outperform placebo in treating depression.

150. In making and disseminating the statements alleged herein, Pfizer knew or should

have known that the statements were untrue or misleading, and that it acted in violation of

California’s False Advertising Law. Pfizer deliberately chose to engage in false advertising by

using a misleading and deceptive drug label which had the effect of inducing Plaintiff and the

California Consumer Class to purchase and ingest Zoloft.

151. Pfizer’s misrepresentations of material facts related to Zoloft, as detailed above,

constitute false and misleading advertising in violation of California’s False Advertising Law.

152. In addition, Pfizer has directly advertised to Plaintiff and the California Consumer

Class by representing that Zoloft is very effective at treating depression and indicating that

Zoloft is categorically superior to placebo in treating depression. The volume of advertisements

directed at California consumers between 1991 and 2012 is substantial.

153. Many advertisements directed toward Plaintiff and the California Consumer Class

involved a little balloon-shaped cartoon character who would bounce around feeling either

depressed or happy depending on whether it had recently taken Zoloft. Pfizer broadly released

commercials depicting the balloon-cartoon after 2001.


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154. One commercial, which Plaintiff saw and relied on prior to taking Zoloft, was one

of Pfizer’s most successful advertisements. 15 The commercial was designed to convince

consumers that Zoloft was very effective at treating depression. It begins with the balloon-

cartoon looking sad under a rain cloud.

A voice-over states:

You know when you feel the weight of sadness. [sound of rain] You may feel exhausted, hopeless, and anxious. [whimper] Whatever you do, you feel lonely and don’t enjoy the things you once loved. [sad moan] Things just don’t feel like they used to. These are some symptoms of depression: a serious medical condition affecting over 20 million Americans.

The commercial then goes into a description of how depression works, relying on the chemical

imbalance theory that has been rejected by scientists.16

As happy music starts, the voice-over states: 15 Full commercial available at http://www.youtube.com/watch?v=6vfSFXKlnO0, last

accessed on January 29, 2013 at 3:25 p.m. 16 See, e.g., Ronald Pies, Psychiatry’s New Brain-Mind and the Legend of the ‘Chemical

Imbalance, Psychiatric Times, July 11, 2011(“[T]he ‘chemical imbalance’ image has been vigorously promoted by some pharmaceutical companies, often to the detriment of our patients’ understanding. . . In truth, the chemical imbalance notion was always a kind of urban legend – never a theory seriously propounded by well-informed psychiatrists.”); Jeffrey R. Lacasse and Jonathan Leo, Serotonin and Depression: A Disconnect between the Advertisements, 2 PLOS MEDICINE 1211-16 (December 2005) (“Contemporary neuroscience research has failed to confirm any serotonergic lesion in any mental disorder, and has in fact provided significant counterevidence to the explanation of a simple neurotransmitter deficiency.”) .


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While the cause is unknown, depression may be related to an imbalance of natural chemicals between nerve cells in the brain. Prescription Zoloft works to correct this imbalance. You just shouldn’t have to feel this way anymore.

The commercial then cuts to the cartoon-character, smiling, with birds chirping.

The commercial then begins to list the various potential side-effects of taking Zoloft while the

balloon-cartoon proceeds to bounce along the Zoloft logo.

The voice-over states:

Only your doctor can diagnose depression. Zoloft is not for everyone. People taking MAOIs or pimozides shouldn’t take Zoloft. Side effects may include dry mouth, insomnia, sexual side effects, diarrhea, nausea, and sleepiness. Zoloft is not habit-forming. Talk to your doctor about Zoloft. The number-one-prescribed brand of its kind.

The commercial concludes with the Zoloft Logo, accompanied by the symbolic bluebird of

happiness, as the voice-over touts Zoloft’s efficacy in treating depression: “Zoloft. When you

know more about what’s wrong, you can help make it right.”


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155. After seeing this commercial, Plaintiff, like numerous consumers within

California, was excited about purchasing and ingesting Zoloft. She specifically relied on this

advertisement in making her decision to purchase and ingest Zoloft. This advertisement is

deeply misleading because it fails to disclose material information about how Zoloft compares to

a placebo, suggesting that Zoloft is a very effective treatment for depression without providing

any of the necessary contextual facts to understand what that means.

156. Many of the California Consumer Class members saw this famous Zoloft

commercial, and Pfizer directed numerous commercials which expressed the materially same

message to consumers within California.

157. The above-described commercial and magazine ads are just a few of the

thousands of advertisements Pfizer directed toward the California Consumer Class designed to

mislead consumers about Zoloft’s efficacy.

158. As a result of Pfizer’s deceptive and unlawful marketing of Zoloft, Pfizer has

improperly and illegally obtained money from Plaintiff and the California Consumer Class.

159. Accordingly, pursuant to California’s False Advertising Law, specifically Cal.

Bus. & Prof. Code § 17535, Plaintiff and the California Consumer Class seek an order of this

Court requiring Pfizer to fully disclose the true nature of its misrepresentations to consumers and

healthcare professionals, disgorging Pfizer’s ill-gotten gains and/or awarding full restitution of

all monies wrongfully acquired by means of its false advertising in California, enjoining Pfizer

from continuing to violate California’s False Advertising Law in its sale and marketing of Zoloft,

awarding those damages available under California law, and for such other relief as set forth

below.

EXEMPLARY DAMAGES ALLEGATIONS



161. Pfizer’s conduct as alleged herein was done with oppression, fraud, and malice.

Pfizer was fully aware of Zoloft’s lackluster efficacy data as documented in its own clinical trials

and internal company documents. Nonetheless, Pfizer deliberately crafted its drug label to


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mislead consumers and prescribing healthcare professionals. This was not done by accident or

through some justifiable negligence. Rather, Pfizer knew that it could turn a profit by

convincing consumers and prescribing healthcare professionals that Zoloft was very effective at

treating depression, and that full disclosure of Zoloft’s efficacy data would limit the amount of

money Pfizer would make selling Zoloft in California. This was accomplished not only through

Zoloft’s misleading drug label, but through a comprehensive scheme of selective publishing,

ghostwriting, paying KOLs, and misleading advertising as more fully alleged throughout this

Complaint. Plaintiff and the California Consumer Class were robbed of their right to make an

informed decision about whether to purchase and ingest a drug with many known side effects.

Such conduct was done with conscious disregard of Plaintiff’s and the California Consumer

Class’ rights.

162. There is no indication that Pfizer will stop its deceptive and unlawful marketing

practices unless it is punished and deterred. Accordingly, Plaintiff requests, on behalf of herself

and the California Consumer Class, punitive damages against Pfizer for its egregious violations

of California consumer protection law.

DEMAND FOR JURY TRIAL

163. Plaintiff respectfully requests a trial by jury on all claims friable as a matter of

right.

PRAYER FOR RELIEF

164. WHEREFORE, Plaintiff, individually and on behalf of the California Consumer

Class described herein, prays for the following relief:

a. Find that this action satisfies the prerequisites for maintenance of a class action

pursuant to Federal Rules of Evidence 23(a) and (b)(3), and certify a California

Consumer Class described more fully herein.

b. Designate Plaintiff as a representative for the California Consumer Class and her

counsel as Class counsel.

c. Issue a judgment against Pfizer that:

i. Permanently enjoins Pfizer from performing further acts in violation of the


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various California consumer protection statutes, alleged in Counts I, II, and

III.

ii. Grants Plaintiff and the California Consumer Class a refund of moneys

acquired by Pfizer by means of its deceptive and unlawful marketing of Zoloft

in California;

iii. Grants Plaintiff and the California Consumer Class an award of actual

damages and/or disgorgement of Pfizer’s profits from its deceptive and

unlawful marketing of Zoloft in violation of the California consumer

protection law;

iv. Grants Plaintiff and the California Consumer Class any actual or

compensatory damages in such amount to be determined at trial and as

provided by applicable law;

v. Grants Plaintiff and the California Consumer Class exemplary and punitive

damages sufficient to punish and deter Pfizer and others from future deceptive

and unlawful marketing practices;

vi. Grants Plaintiff and California Consumer Class pre-judgment and post-

judgment interest;

vii. Grants Plaintiff and California Consumer Class reasonable attorneys’ fees and

costs of suit; and

viii. Grants Plaintiff and California Consumer Class such other and further relief as

the Court deems just and proper under the circumstances.

DATED: March 12, 2014 Respectfully submitted, PENDLEY, BAUDIN & COFFIN, L.L.P. /s/ Christopher L. Coffin Christopher L. Coffin

Nicholas R. Rockforte * David M. Hundley *

1515 Poydras St., Suite 1400 New Orleans, LA 70112 Telephone: (504) 355-0086


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KELLER ROHRBACK L.L.P. Michael D. Woerner * Gretchen Freeman Cappio * Benjamin Gould Alison Gaffney * 1201 Third Avenue, Suite 3200 Seattle, Washington 98101 Telephone: (206) 623-1900 KELLER ROHRBACK L.L.P. Juli E. Farris Khesraw Karmand 1129 State Street, Suite 8 Santa Barbara, California 93101 Telephone: (805) 456-1496

LAW OFFICE OF S. SAMUEL GRIFFIN S. Samuel Griffin [email protected] 1130 Piedmont Ave, N.E., # 908 Atlanta, GA 30309 Telephone: (404) 683-1915 Attorneys for Plaintiff Laura A. Plumlee

* Pro hac vice application pending


Debra Wilcher

From: Debra WilcherSent: Thursday, March 13, 2014 11:08 AMTo: Zoloft-PlumleeSubject: Zoloft Amended ComplaintImportance: Low

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3/18/2014

FYI ---

From: Mike Woerner Sent: Thursday, March 13, 2014 11:05 AM To: Debra Wilcher Subject: RE: Activity in Case 5:13-cv-00414-LHK Plumlee v. Pfizer, Inc Amended Complaint I believe it is because the word "exhibit b" mistakenly appeared in the document and was removed.

From: Debra Wilcher Sent: Thursday, March 13, 2014 10:58 AM To: Mike Woerner Subject: FW: Activity in Case 5:13-cv-00414-LHK Plumlee v. Pfizer, Inc Amended Complaint Do you happen to know why this was re-filed?

From: [email protected] [mailto:[email protected]] Sent: Thursday, March 13, 2014 10:13 AM To: [email protected] Subject: Activity in Case 5:13-cv-00414-LHK Plumlee v. Pfizer, Inc Amended Complaint This is an automatic e-mail message generated by the CM/ECF system. Please DO NOT RESPOND to this e-mail because the mail box is unattended. ***NOTE TO PUBLIC ACCESS USERS*** Judicial Conference of the United States policy permits attorneys of record and parties in a case (including pro se litigants) to receive one free electronic copy of all documents filed electronically, if receipt is required by law or directed by the filer. PACER access fees apply to all other users. To avoid later charges, download a copy of each document during this first viewing. However, if the referenced document is a transcript, the free copy and 30 page limit do not apply.

U.S. District Court

California Northern District

Notice of Electronic Filing The following transaction was entered by Coffin, Christopher on 3/13/2014 at 10:12 AM and filed on 3/13/2014 Case Name: Plumlee v. Pfizer, IncCase Number: 5:13-cv-00414-LHKFiler: Laura A PlumleeDocument Number:116

Docket Text: AMENDED COMPLAINT CORRECTION OF DOCKET # [115] against Pfizer, Inc. Filed byLaura A Plumlee. (Coffin, Christopher) (Filed on 3/13/2014)

5:13-cv-00414-LHK Notice has been electronically mailed to: Allen Ruby [email protected], [email protected], [email protected] Bijan Esfandiari [email protected] Christopher Luke Coffin [email protected], [email protected], [email protected] Cynthia Lynn Garber [email protected] David M Hundley [email protected] Gretchen Freeman Cappio [email protected], [email protected] Juli E. Farris [email protected], [email protected], [email protected] Karin A. Kramer [email protected], [email protected], [email protected], [email protected], [email protected], [email protected] Khesraw Karmand [email protected] Leeron Morad [email protected], [email protected] Mark S. Cheffo [email protected] Michael Dean Woerner [email protected] Michael L. Baum [email protected] Nicholas R Rockforte [email protected] Raoul Dion Kennedy [email protected], [email protected], [email protected], [email protected] Robert Brent Wisner [email protected], [email protected], [email protected], [email protected], [email protected], [email protected] S. Samuel Griffin [email protected] 5:13-cv-00414-LHK Please see Local Rule 5-5; Notice has NOT been electronically mailed to: Alison Gaffney Keller Rohrback LLP 1201 Third Avenue Suite 3200 Seattle, WA 98101

Page 2 of 3

3/18/2014

Benjamin Gould Kelly Rohrback LLP 1201 Third Avenue Suite 3200 Seattle, WA 98101 Patrick Wayne Pendley Pendley Baudin & Coffin LLP 1515 Poydras Street Suite 1400 New Orleans, LA 70112 Stanley P. Baudin Pendley Baudin & Coffin , LLP 1515 Poydras Street Suite 1400 New Orleans, LA 70112

The following document(s) are associated with this transaction:

Document description:Main Document Original filename:C:\fakepath\Plumlee Corrected AC.pdf Electronic document Stamp: [STAMP CANDStamp_ID=977336130 [Date=3/13/2014] [FileNumber=10475832-0][1ce52eee0e243f9b93a419727c9ca422a767793eb99be604249b7913059dc12e38cc c0415f534f00da006aef76eeeec7b616c30fd833cfe7775abf6881cfe5d6]]

Page 3 of 3

3/18/2014

christopher l. coffin (pro hac vice michael d. woerner ...corrected)_dkt116... · zoloft’s...

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